NCT01727388

Brief Summary

Digital rectal examination is an act clinically performed daily by physicians and surgeons. It remains the key diagnostic test and directs the therapeutic management of cancer of the lower and middle rectum. It can be done in two main positions: lateral decubitus, and supine. However, no randomized study in colorectal surgery is not interested in evaluating the best position to perform a full rectal exam.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
320

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Nov 2012

Shorter than P25 for phase_3

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 22, 2012

Completed
10 days until next milestone

Study Start

First participant enrolled

November 1, 2012

Completed
15 days until next milestone

First Posted

Study publicly available on registry

November 16, 2012

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2013

Completed
Last Updated

September 19, 2025

Status Verified

September 1, 2025

Enrollment Period

4 months

First QC Date

October 22, 2012

Last Update Submit

September 16, 2025

Conditions

Colon CancerUpper Rectum CancerDiverticulitisRectal BleedingHernia

Keywords

rectal examinationcolorectal cancer

Outcome Measures

Primary Outcomes (1)

  • realization of a full digital rectal examination

    Full digital rectal examination is defined by a rectal examination for investigating the superior pole of the prostate, to examine the entire circumference and the rectal sphincter.

    The consult could be done prior to the surgery or one month after the surgery

Secondary Outcomes (4)

  • assessment of sphincter according to the DRESS score

    The consult can be performed prior to the surgery or one month after the surgery

  • missing information during the rectal examination

    The consult can be performed prior to the surgery or one month after the surgery

  • Conversion rate decided by the examiner

    The consult can be performed prior to the surgery or one month after the surgery

  • Evaluation of the position by the patient

    The consult can be performed prior to the surgery or one month after the surgery

Study Arms (2)

lateral decubitus

EXPERIMENTAL

The digital rectal examination is performed in lateral decubitus i.e. curled up position . The patient in left lateral decubitus if the examiner is right handed and right lateral decubitus if the examiner is left handed.

Procedure: lateral decubitus

supine decubitus

ACTIVE COMPARATOR

The digital rectal examination is performed supine, spread legs, feet on the examination table. The examiner is in the patient's right side if he is right handed and in the patient's left side if he is left-handed.

Procedure: supine decubitus

Interventions

lateral decubitusPROCEDURE
lateral decubitus
supine decubitusPROCEDURE
supine decubitus

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • colon or upper rectum cancer operated or not
  • recurrent of colon or upper rectum cancer
  • rectal bleeding
  • hernia

You may not qualify if:

  • woman
  • paraplegic man
  • bedridden patient
  • current or previous pelvic radiotherapy
  • History of prostatectomy
  • emergency

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Amiens Universitary Hospital

Amiens, France

Location

Beauvais General Hospital

Beauvais, France

Location

Related Publications (1)

  • Sabbagh C, Mauvais F, Vecten A, Ainseba N, Cosse C, Diouf M, Regimbeau JM. What is the best position for analyzing the lower and middle rectum and sphincter function in a digital rectal examination? a randomized, controlled study in men. Dig Liver Dis. 2014 Dec;46(12):1082-5. doi: 10.1016/j.dld.2014.08.045. Epub 2014 Sep 22.

    PMID: 25245464RESULT

MeSH Terms

Conditions

Colonic NeoplasmsRectal NeoplasmsDiverticulitisGastrointestinal HemorrhageHerniaColorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal DiseasesDiverticular DiseasesGastroenteritisHemorrhagePathologic ProcessesPathological Conditions, Signs and SymptomsPathological Conditions, Anatomical

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 22, 2012

First Posted

November 16, 2012

Study Start

November 1, 2012

Primary Completion

March 1, 2013

Study Completion

March 1, 2013

Last Updated

September 19, 2025

Record last verified: 2025-09

Locations

FR(2)